Ascites Hepatic
Conditions
Keywords
paracentesis, cirrhosis, ascites
Brief summary
Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
Detailed description
This study is a multi-center, prospective, interventional study, in which subjects who meet the selection criteria are registered at each institution during the study period from the date of research approval. Regardless of the order, paracentesis using KARAHOC and conventional angiocatheter will be performed once in all patients. The criteria for successful paracentesis is set as 3L or more of ascites drainage. During paracentesis, albumin will be infused in all patients. Heart rate and blood pressure will be measured before the procedure and right after the completion of drainage, and 30 minutes later. The incidence of complications will be compared between two methods. In addition, patient and operator satisfaction will be investigated using a visual analogue scale.
Interventions
DEVICEKARAHOC device
After leaving a mark on the part where the puncture is to be performed using a pen, sterilization dressing are performed, local anesthesia is performed aseptic then ascites paracentesis by KARAHOC device.
DEVICEAngiocatheter
After leaving a mark on the part where the puncture is to be performed using a pen, sterilization dressing are performed, local anesthesia is performed aseptic then ascites paracentesis by angiocatheter
Sponsors
Sang Gyune Kim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multi-center, prospective, interventional study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult over the age of 19 * Patients with pathological or clinical diagnosis of liver cirrhosis * Patients with Grade 2 or higher grade of ascites as a complication due to portal hypertension * Patients requiring periodic paracentesis * Patients consent to this study
Exclusion criteria
(If at least one of the following conditions apply) * Patients with ascites due to peritoneal metastasis due to malignant tumor * Patients with high bleeding risk (PT INR\>3, PLT\<30,000/mm3) difficult to perform ascites puncture * Patients with hepatic encephalopathy or hepatorenal syndrome(HRS) * Patients with severe cardiovascular disease, lung disease, or DIC * Patients refusing paracentesis * Patients who can control ascites using diuretics * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis | through study completion, an average of 1 year | The criterion for successful paracentesis is defined as drainage of 3L or more at an initial attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of complication rate | through study completion, an average of 1 year | the frequency of bleeding, hypotension, acute kidney injury, infection |
| operator satisfaction for each procedure | through study completion, an average of 1 year | measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome |
| patient satisfaction for each procedure | through study completion, an average of 1 year | measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome |
| Number of Participants with repeated paracentesis | through study completion, an average of 1 year | Whether to do paracentesis again due to initial failure or catheter dislocation |
Countries
South Korea
Outcome results
None listed